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"Timely treatment with appropriate therapies can help mitigate damage caused by MS and delay long-term disability for people with the disease."

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen
(NASDAQ: BIIB) announced new real-world data that show treatment with
its leading multiple sclerosis (MS) therapies, TECFIDERA®
(dimethyl fumarate) and TYSABRI® (natalizumab), early in the
course of the disease may improve outcomes for people living with
relapsing MS. These data were presented at the 69th annual meeting of
the American Academy of Neurology (AAN) in Boston.

MS is a chronic, often disabling disease that attacks and causes
inflammation within the central nervous system. Initiating an
appropriate disease modifying therapy soon after diagnosis has been
shown to slow the physical and cognitive decline associated with MS and
may prevent the accumulation of future disability, allowing people
living with MS to stay active longer.1,2

“The new real-world TECFIDERA and TYSABRI data presented at AAN
emphasize the importance of effective treatment early in the course of
one’s disease,” said Kate Dawson, M.D., vice president, U.S. Medical at
Biogen. “Timely treatment with appropriate therapies can help mitigate
damage caused by MS and delay long-term disability for people with the
disease.”

Comparative Effectiveness Data Further Support Use of TECFIDERA in
Early MSTECFIDERA is the world’s most prescribed oral
therapy for MS. A comparison of real-world data provides further
evidence of its strong efficacy relative to other oral MS therapies,
both in newly-treated MS patients and those previously treated with a
prior disease modifying therapy (DMT). Researchers used U.S. insurance
claims data to compare the time to first relapse among patients
initiating TECFIDERA versus fingolimod or teriflunomide. These results
show that TECFIDERA significantly reduced the risk of relapse by 30
percent compared to teriflunomide (hazard ratio [HR]: 1.302; p<0.01) in
newly diagnosed patients and those previously treated with a prior DMT,
and had comparable efficacy to fingolimod (HR: 0.995; p=0.94). These
data are consistent with other comparative effectiveness data showing
similar results to oral therapies and greater efficacy to interferon
beta and glatiramer acetate.

Subgroup analyses of the open-label studies PROTEC and RESPOND assessed
TECFIDERA in early MS and early switch patients, respectively. Results
show that TECFIDERA significantly reduced the annualized relapse rate
(ARR) over one year in the early MS subgroups, including those who
switched to TECFIDERA from a prior DMT. Additional data presented at the
meeting affirm the well-characterized, long-term safety profile of
TECFIDERA in patients treated for up to nine years.

Early and Continued TYSABRI Treatment Leads to Better Outcomes in
MS Patients with High Disease ActivityTYSABRI is the only
targeted high-efficacy MS treatment with more than 10 years of clinical
experience. New data from the TYSABRI Observational Program (TOP)
reinforce the proven efficacy of TYSABRI and demonstrate that early and
continued treatment leads to better clinical outcomes.

A subgroup analysis from TOP compared outcomes for treatment-naive
patients who began taking TYSABRI shortly after MS symptom onset (≤1
year) with those who initiated TYSABRI after experiencing MS symptoms
for some time (>1 and ≤5 years, or >5 years). Annualized relapse rate
and disability worsening or improvement, as measured by the Expanded
Disability Status Scale (EDSS), were assessed. Results show that, over
three years, the likelihood of disability improvement was significantly
greater for patients treated with TYSABRI within one year of MS symptom
onset (49.3%), than for those treated between one to five years (38.1%)
or more than five years (26.3%) following symptom onset. TYSABRI
treatment also significantly reduced ARR compared with baseline in all
three cohorts. Additional TOP data presented at the meeting show
patients who continued TYSABRI treatment experienced better clinical
outcomes than those who switched to another therapy.

About TECFIDERA®TECFIDERA is an oral
therapy for relapsing forms of MS, including relapsing-remitting MS, the
most common form of MS. More than 240,000 patients have been treated
with TECFIDERA worldwide.3

TECFIDERA has been proven to reduce the rate of MS relapses, slow the
progression of disability, and impact the number of MS brain lesions,
while demonstrating a favorable benefit-risk profile in people with
relapsing forms of MS, notably newly diagnosed and early switch
populations. 4 In clinical trials, the most common
adverse events associated with TECFIDERA were flushing and
gastrointestinal (GI) events. Other side effects include a decrease in
mean lymphocyte counts during the first year of treatment, which then
plateaued, and liver function abnormalities, which resolved upon
treatment discontinuation. TECFIDERA is contraindicated in patients with
a known hypersensitivity to dimethyl fumarate or any of the excipients
of TECFIDERA. Rare cases of progressive multifocal leukoencephalopathy
(PML), a rare opportunistic viral infection of the brain which has been
associated with death or severe disability, have been seen with
TECFIDERA patients in the setting of prolonged moderate to severe
lymphopenia.

The efficacy and safety of TECFIDERA have been studied in a large,
global clinical program, which includes an ongoing long-term extension
study.

For additional important safety information, and the United States full
prescribing information, please visit www.tecfidera.comor your respective country’s website.

About TYSABRI®TYSABRI is a disease modifying
therapy (DMT) approved in more than 80 countries including the United
States, the European Union, Canada, Australia and Switzerland. In the
United States, TYSABRI is indicated as monotherapy for the treatment of
patients with relapsing forms of MS. In the European Union, it is
indicated as single disease modifying therapy in adults with highly
active relapsing-remitting multiple sclerosis (RRMS) for patients with
highly active disease activity despite a full and adequate course of
treatment with at least one DMT or patients with rapidly evolving severe
RRMS. TYSABRI is proven effective, with 10 years of experience in
treating RRMS, and more than 167,000 people treated worldwide and
559,000 patient-years of experience.5

TYSABRI is a monoclonal antibody that selectively binds to α4-integrin
and is thought to interrupt the activity of inflammatory cells in MS
patients by blocking the interaction between α4β1-integrin and vascular
cell adhesion molecule-1. Disruption of these molecular interactions
prevents transmigration of leukocytes across the endothelium into
inflamed parenchymal tissue. The specific mechanism(s) by which TYSABRI
exerts its effects in MS have not been fully defined.

TYSABRI has advanced the treatment of MS patients with its proven
ability to slow the progression of disability, reduce relapse rates, and
impact the number of MRI brain lesions with a well-characterized safety
profile. Data from the Phase 3 AFFIRM trial, which was published in the New
England Journal of Medicine, showed that at two years, TYSABRI
treatment led to a 68 percent relative reduction (p<0.001) in the
annualized relapse rate when compared with placebo and reduced the
relative risk of disability progression by 42 to 54 percent (12-24-week
sustained respectively, both p<0.001).

TYSABRI increases the risk of PML, a rare opportunistic viral infection
of the brain which has been associated with death or severe disability.
Risk factors that increase the risk of PML are the presence of anti-JCV
antibodies, prior immunosuppressant use and longer TYSABRI treatment
duration. Patients who have all three risk factors have the highest risk
of developing PML. TYSABRI increases the risk of developing encephalitis
and meningitis caused by herpes simplex and varicella zoster viruses and
clinically significant liver injury has also been reported in the
post-marketing setting. Serious, life-threatening, and sometimes fatal
cases have been reported in the postmarketing setting in MS patients
receiving TYSABRI. Other serious adverse events that have occurred in
TYSABRI-treated patients include hypersensitivity reactions (e.g.,
anaphylaxis) and infections, including opportunistic and other atypical
infections. Clinically significant liver injury has also been reported
in the post-marketing setting.

The overall benefit-risk profile of TYSABRI remains positive. For
additional important safety information and the full United States
prescribing information which includes a full list of adverse events,
please visit www.tysabri.com or
your respective country’s website.

About BiogenThrough cutting-edge science and medicine,
Biogen discovers, develops and delivers innovative therapies worldwide
for people living with serious neurological and neurodegenerative
diseases. Founded in 1978, Biogen is a pioneer in biotechnology and
today the Company has the leading portfolio of medicines to treat
multiple sclerosis, has introduced the first and only approved treatment
for spinal muscular atrophy, and is at the forefront of neurology
research for conditions including Alzheimer’s disease, Parkinson’s
disease and amyotrophic lateral sclerosis. Biogen also manufactures and
commercializes biosimilars of advanced biologics. For more information,
please visit www.biogen.com.
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Safe HarborThis press release contains forward-looking
statements, made pursuant to the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995, including statements relating
to the potential benefits, safety and efficacy of TECFIDERA and TYSABRI
and the results of certain real-world data. These forward-looking
statements may be accompanied by words such as “anticipate,” “believe,”
“could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,”
“potential,” “possible,” “will” and other words and terms of similar
meaning. You should not place undue reliance on these statements or the
scientific data presented. Drug development and commercialization
involve a high degree of risk. Factors which could cause actual results
to differ materially from Biogen’s current expectations include
unexpected concerns that may arise from additional data or analysis;
regulatory authorities may require additional information or further
studies, or may fail to approve or may delay approval of Biogen’s drug
candidates or expansion of product labeling; or Biogen may encounter
other unexpected hurdles which may be impacted by, among other things,
the occurrence of adverse safety events, failure to obtain regulatory
approvals in certain jurisdictions, failure to protect intellectual
property and other proprietary rights, product liability claims or third
party collaboration risks, and the other risks and uncertainties that
are described in the Risk Factors section of Biogen’s most recent annual
or quarterly report and in other reports Biogen has filed with the U.S.
Securities and Exchange Commission. These statements are based on our
current beliefs and expectations and speak only as of the date of this
press release. We do not undertake any obligation to publicly update any
forward-looking statements, whether as a result of new information,
future developments or otherwise.

1 Kappos, L., Freedman, M., Polman, C., et, al. (2007).
Effect of early versus delayed interferon beta-1b treatment on
disability after a first clinical event suggestive of multiple
sclerosis: A 3-year follow-up analysis of the BENEFIT study. The Lancet,
389-397.2 Goodin, D., & Bates, D. (2009). Review:
Treatment of early multiple sclerosis: The value of treatment initiation
after a first clinical episode. Multiple Sclerosis, 1175-1182.3
Combined post-marketing and clinical trials exposure to TECFIDERA as of
31 January 2017.4 TECFIDERA is approved in the European
Union for relapsing-remitting multiple sclerosis.5 As
of 28 February 2017.